Nuvalent, Inc. is a clinical stage biopharmaceutical company, which focuses on creating precisely targeted therapies for patients with cancer. Its pipeline includes ROS1 NSCLC, ALK NSCLC and HER2 NSCLC. The company was founded by Matthew D. Shair in January 2017 and is headquartered in Cambridge, MA.
Clinical Trials
8
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2017
Available
2
25.0%
Recruiting
6
75.0%
No approval data available
- GSK has secured full global rights to Chimagen Biosciences' unnamed trispecific T-cell engager for multiple myeloma in a deal worth up to $750 million. - The preclinical asset is designed to bind T cells while targeting two tumor-associated antigens, aiming for deeper responses and better tolerability than existing engagers. - GSK plans to begin Phase 1 testing in 2027, adding to a myeloma portfolio anchored by the BCMA-directed antibody-drug conjugate Blenrep. - The deal is GSK's second with Chimagen, following the 2024 licensing of the CD19/CD20-targeted T-cell engager CMG1A46 for B-cell malignancies and autoimmune disease.
- In the Phase I/II ARROS-1 trial, zidesamtinib produced a 94% objective response rate in 94 TKI-naive patients with advanced ROS1-positive NSCLC by blinded independent central review. - Among 10 evaluable patients with CNS metastases, intracranial objective response rate reached 100%, including a 70% intracranial complete response rate. - GSK plans a supplemental new drug application to the FDA later this year seeking first-line approval, after Jideytro's July approval in previously treated disease. - Treatment-related adverse events led to dose reductions in 11% and discontinuation in 1%, with peripheral edema the most common event at 34%.
- GSK's new CEO Luke Miels is executing a three-year, multibillion-dollar restructuring to save roughly $2.5 billion annually ahead of looming patent expirations on blockbuster drugs like dolutegravir. - Novo Nordisk's Maziar Mike Doustdar is working to regain obesity-market momentum lost to Eli Lilly, buoyed by strong uptake of the Wegovy pill despite recent pipeline setbacks. - Sanofi's Dr. Belén Garijo is steering the company toward a post-Dupixent future, with the blockbuster facing loss of exclusivity as soon as 2031. - All three leaders took the helm within the last year at pivotal moments, each aiming to set up the next phase of growth for their companies.
- GSK will discontinue development of camlipixant for refractory chronic cough after the drug failed to meet key goals across two late-stage trials, sending shares down approximately 4%. - The 50 mg dose reduced daily coughing over 12 weeks in one trial but failed to replicate the result in a second 24-week study; the 25 mg dose showed no clear benefit in either. - GSK stated the limited benefit means the drug was "unlikely to transform patient care," though it will continue testing camlipixant for irritable bowel syndrome. - The failure raises questions about GSK's £40 billion 2031 revenue target, with camlipixant having been positioned as one way to close the gap from analyst forecasts of roughly £35 billion.
- GSK has agreed to acquire Boston-based oncology firm Nuvalent for $10.6 billion, marking its largest deal in over a decade. - The acquisition includes two late-stage lung cancer candidates, zidesamtinib and neladalkib, both with FDA breakthrough therapy and orphan drug designations. - Subject to FDA approval, the drugs are expected to launch in 2026 with multi-blockbuster potential, contributing to revenue growth from 2027. - The deal aligns with GSK's strategy of acquiring assets with validated targets that address efficacy and tolerability limitations of existing standard-of-care therapies.
- Guardant Health and Nuvalent announced a multi-year strategic collaboration to develop companion diagnostics for targeted cancer therapies using Guardant's tissue and liquid biopsy portfolio. - The partnership will support clinical development of Nuvalent's oncology pipeline targeting ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer. - The collaboration reflects the growing importance of biomarker-driven approaches in oncology drug development for identifying appropriate patient populations and improving trial efficiency. - Both companies plan to collaborate on global commercialization of approved product candidates and companion diagnostics across major international markets.
- The SUCCEED study launches as a landmark remote clinical trial allowing small cell lung cancer patients to participate from home, addressing location barriers that have historically limited research in this aggressive disease. - Several phase 1b and phase 2 trials have initiated patient dosing across multiple cancer types, including urothelial cancer treatment with FX-909 and advanced solid tumors with AI-081 bispecific antibody. - Completed early-phase studies show promising results, with elraglusib demonstrating activity in treatment-resistant Ewing sarcoma and the phase 3 ALKAZAR trial beginning enrollment for ALK-positive lung cancer patients.
- Nuvalent will host a webcast on June 24, 2025, to discuss pivotal data for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer from the ARROS-1 Phase 1/2 trial. - Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor designed to overcome resistance to current ROS1 inhibitors and address brain metastases in cancer patients. - The drug has received breakthrough therapy designation for ROS1-positive metastatic NSCLC patients previously treated with 2 or more ROS1 tyrosine kinase inhibitors. - The ARROS-1 trial's Phase 2 portion is designed with registrational intent for both TKI-naïve and TKI pre-treated patients with ROS1-positive NSCLC.
• Nuvalent will present preliminary dose-escalation data from the ALKOVE-1 Phase 1/2 trial of NVL-655, marking the first clinical disclosure for this next-generation ALK inhibitor. • NVL-655 is designed to overcome key limitations of existing ALK inhibitors, including resistance mutations, poor brain penetrance, and CNS adverse events. • The drug targets advanced ALK-positive non-small cell lung cancer and has been engineered to remain active against multiple resistance mutations including the challenging G1202R solvent front mutation. • The presentation will occur at the 35th AACR-NCI-EORTC Symposium in Boston on October 13, 2023, with a planned conference call the same day.
• Nuvalent is preparing to submit its first New Drug Application by mid-2025 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC, with pivotal data expected in the first half of 2025. • The company plans to initiate the ALKAZAR Phase 3 trial in the first half of 2025, evaluating neladalkib versus alectinib for front-line treatment of ALK-positive NSCLC patients. • With $1.1 billion in cash reserves expected to fund operations into 2028, Nuvalent is transitioning toward becoming a fully integrated commercial-stage biopharmaceutical company.
